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Title:
Phase II Study of Olaparib in Men with High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, with Integrated Biomarker Analysis
Protocol Number:
J16163
Phase:
Phase II
Physician:
Emmanuel Antonarakis
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
This study is for men with non-metastatic biochemically-recurrent prostate cancer to determine if Olaparib given by mouth twice daily reduces PSA by 50%.
Eligibility:
-PSA doubling time of less than or equal to to 6 months based on 3 consecutive measurements collected in the past 12 months at least 4 weeks apart.-Minimum PSA of 1.0ng/mL-No evidence of metastatic disease on CT scan and bone scan.-Adequate kidney and liver function tests.-Serum Testosterone greater than or equal to 150ng/dL.-Prior local therapy with prostatectomy required with available tissue for genomic testing.-No prior ADT in the past 6 months.-No prior oral anti-androgen in the past 6 months.-No prior treatment with IV chemotherapy.-No history of active hepatitis B or C.
Treatment:
Patients will be given an oral medication of Olaparib 300mg twice daily to take continuously until disease progression as defined by the study or unacceptable side effects. Patients will return to clinic to have labs drawn for safety and research every cycle. Each cycle is 28 days and radiographic testing (CT and bone scan) will be done every 6 months while on therapy.
Population:
Adult
Last Update
03/05/2019 05:03 AM